Formaldehyde (Formalin)

Formaldehyde (Formalin)
1. Use of Formaldehyde (Formalin)
Formaldehyde is the primary preservative/fixative used within the
Anatomic Pathology Division laboratories in a 10% formalin solution.
The Pathology Department uses formalin to fix grossed tissue, autopsy
specimens, and Cytology cell blocks.
Formaldehyde is a colorless, aqueous solution that has an irritating
pungent odor and is classified as an upper respiratory irritant because
of its high solubility in water.
2. Hazards Associated with Exposure to Formaldehyde (Formalin)
There are several health effects, both short and long-term, that can
result from exposure or over-exposure to formaldehyde. The following
is a list of signs, symptoms, and actions to take in the event of
sensitization to and/or acute health effects from exposure/overexposure to formaldehyde:
o Skin contact: Formaldehyde is a severe skin irritant and sensitizer.
Contact with formaldehyde solutions, vapor or resins can cause
eczema (dry, flaking and itching skin) and in extreme cases can
lead to allergic dermatitis or hives.
o Clothing saturation: The aforementioned symptoms can also be
caused by contact with clothing contaminated with formaldehyde. In
the event that clothing is saturated with formaldehyde, remove
contaminated clothing immediately, wash the affected area with
soap for at least 15 minutes, and report the incident to your
supervisor and seek medical attention if necessary.
o Eye contact: Exposure to formaldehyde vapor can cause
reddening and a burning sensation in the eyes, accompanied by
tear production. Formaldehyde solutions coming into direct contact
with the eye can cause serious damage to the cornea, possibly
leading to blindness. In the event formaldehyde is introduced to the
eyes, wash the eyes immediately with large amounts of water and
seek medical attention immediately.
o Ingestion: Ingestion of small amounts of concentrated
formaldehyde solution can cause severe irritation of the mouth,
throat and stomach, and can lead to loss of consciousness and
death. Should ingestion occur, provide a conscious victim milk,
activated charcoal or water, and seek immediate medical attention.
o Nose, throat, and lungs: Low ambient concentrations of
formaldehyde can cause irritation of the upper respiratory tract. At
higher concentrations, the effects become more severe, with levels
above 10 ppm causing coughing, chest tightness and difficulty
breathing, and levels of 25 to 30 ppm causing severe respiratory
tract injury. Exposure to 100 ppm is immediately dangerous to life
and health leading to death from throat swelling and chemical burns
to the lungs. At the first sign of any of these symptoms, seek fresh
air and report the incident to your supervisor immediately.
o Respiratory Sensitization: Since formaldehyde is a sensitizer,
repeated exposure to formaldehyde can cause allergic asthma.
Symptoms of asthma include chest tightness, shortness of breath,
wheezing, and coughing.
Chronic health effects (potential) due to long-term exposure to
formaldehyde may be linked to the following:
o Cancer: Although there is no conclusive evidence available to
prove that formaldehyde is a human carcinogen, prolonged
exposure has been associated with cancers of the lung,
nasopharynx, oropharynx, and nasal passages, and it has been
shown to cause cancer in animals. Formaldehyde is therefore
considered to be a probable human carcinogen.
o Mutagen: Formaldehyde is genotoxic in several in-vitro test
systems, showing properties of both an initiator and a promoter.
o Reproductive system: Scientists have made many attempts to
study whether formaldehyde might harm pregnancy or the
reproductive system. The results have been mixed and
complicated. Studies clearly show that formaldehyde does not
cause birth defects. There is some uncertainty whether
formaldehyde might cause spontaneous abortions and sperm
damage. However, it is believed that exposures in most workplaces
probably do not pose any significant risk to pregnancy or the
reproductive system.
Symptoms of Exposure: Because formaldehyde is very water soluble
it affects the mucous membranes. The effects of formaldehyde
exposure can vary from person to person. Typical exposure symptoms
are listed below:
Concentration in Air
0.1-5 ppm
5-20 ppm
20-100 ppm
ppm = parts per million
Eye irritation, tears, skin irritation, respiratory
tract irritation
Burning of eyes and respiratory tract, tears,
difficulty in breathing/coughing
Chest tightening, pain, irregular heartbeat,
severe lung irritation, pulmonary edema, death
in severe cases
Medical Surveillance Program: Employees should immediately
report any adverse signs or symptoms previously presented which they
suspect may be caused by exposure to formaldehyde to his or her
supervisor and seek medical attention from the UMHHC’s Employee
Health Services office.
3. Signage
All designated areas where formaldehyde or formalin solutions are
required to be used or stored will have the following signage posted:
Any container of formaldehyde or formalin solutions should be clearly
labeled with the following:
All secondary containers and/or working solutions/reagents of
formaldehyde will have the following label:
Waste containers of formaldehyde solutions must be immediately
labeled with a UMHHC Hazardous Waste label as soon as the waste is
The following signage will be posted when chemicals are being
changed on the processors in the Histology laboratory:
4. Air monitoring, Results, and Documentation
In the event of odor complaints, overexposure signs and symptoms,
change in personnel, procedure/process, or new equipment,
formaldehyde exposure monitoring may be required to ensure that
employees are not over-exposed to formaldehyde vapors. Monitoring
will be conducted by Safety Management Services (764-4427).
Frequency of monitoring: Exposure monitoring should be conducted
for each job classification and for each work shift. It is critical to repeat
the monitoring process each time there is a change in production,
equipment, process, personnel, or control measures that result in new
or additional exposure to formaldehyde.
The laboratory may discontinue periodic formaldehyde monitoring if
results from 2 consecutive sampling periods taken at least 7 days apart
show that employee exposure is below the action level and the shortterm exposure limit, and 1) no change has occurred in production,
equipment, process, or personnel or control measures that may result
in new or additional exposure to formaldehyde, and 2) there have been
no reports of conditions that may be associated with formaldehyde
If any personnel report signs or symptoms of respiratory or dermal
conditions associated with formaldehyde exposure, the laboratory must
promptly monitor the affected person’s exposure.
Regulatory Exposure Limits: The following standards are applicable
to occupational exposure to Formaldehyde:
o Michigan Department of Consumer and Industry Services
(MIOSHA) Part 306. Formaldehyde
o MIOSHA Permissible Exposure Limits (PEL):
0.75 ppm as an 8 hour Time-Weighted Average (TWA)
2.0 ppm as a 15 minute Short Term Exposure Limit (STEL)
MIOSHA has also established an Action Level of 0.5 ppm,
averaged as an 8 hour TWA.
o The American Council for Governmental Industrial Hygienists
(ACGIH) recommends:
0.3 ppm as a ceiling limit that should not be exceeded at any
time (usually a 15 minute sample if instantaneous
measurements are not feasible).
PELs are the maximum amounts or concentrations of a chemical that a
worker may be exposed to under OSHA regulations. PEL's can be
defined in two different ways:
1. Ceiling values - at no time should this exposure limit be
2. 8-hour Time Weighted Averages (TWA) - are an average value
of exposure over the course of an 8 hour work shift.
Time Weighted Average (TWA) is the permitted exposure limit of
airborne concentrations of substances that a worker may be exposed
to over an eight hour working day for a five day working week. Higher
levels of exposure are permitted provided they are compensated for by
equivalent exposures below the standard during the working day (see
TWA levels are usually lower than ceiling values. Thus, a worker may
be exposed to a level higher than the TWA for part of the day (but still
lower than the ceiling value) as long as he/she is exposed to levels
below the TWA for the rest of the day.
STELs are expressed as airborne concentrations of substances
averaged over a period of fifteen minutes. Workers should not be
exposed at the STEL concentration continuously for longer than fifteen
minutes, or for more than four such periods per working day. A
minimum of sixty minutes should be allowed between successive
exposures at the STEL concentration.
The area supervisor shall report the results of all formaldehyde
monitoring to the person(s) monitored within 15 calendar days of the
date on which the area supervisor receives the results. Notification
must either be in writing, either by distributing copies of the results of
the exposure monitoring to the affected (those conducting the same
job tasks) employees or by posting the results (results should be
posted for a minimum of three days). Once the results have been
reviewed by all affected employees, a copy should be filed in the
Department's Formaldehyde Program and Training Manual. If the PEL
has been exceeded, effected employees must be notified, in writing, of
the corrective action being taken.
TWA measurements may be taken at any time, at the discretion of the
area supervisor. If monitoring results indicate that either the PEL or the
STEL has been exceeded, the use of respirators and/or other
protective equipment is required by all personnel in the area, as soon
as the report is received (NOTE: Gloves, goggles, face shields, and
other protective clothing may be necessary at much lower exposure
levels). OSHA specifies full-facepiece respirators with cartridges
specifically approved for formaldehyde exposure. The employer shall
select protective clothing and equipment based upon the form of
formaldehyde to be encountered, the condition of use, and the hazard
to be prevented. The employer shall provide these protective devices
to the employee at no cost and assure that the employee wears them.
The university/hospital shall establish regulated areas where the
concentration of airborne formaldehyde exceeds either the TWA or the
STEL and post the following signage at all entrance/access ways:
5. Engineering and Safe Work Practices/Administrative Controls
Safe Work Practices/Administrative Controls. Safe work practices
and administrative controls are an important part of a safe working
environment. If an employee is asked to perform a task in a certain
manner to limit the exposure to formaldehyde, then the recommended
procedures should be followed exactly as outlined. In context with
minimizing formaldehyde exposure, the following work practices should
be applied:
o As with any laboratory chemical, do not mouth pipette
formaldehyde solutions.
o Do not eat or drink where formaldehyde is handled, processed, or
stored, since the chemical can be ingested.
o Always wash hands thoroughly after using formaldehyde, even if
gloves are worn.
o Minimize the amount of formaldehyde used by using only the
amount required to perform the required procedure.
o Ensure that formaldehyde containers are appropriately labeled with
proper health hazards.
o A tray should be used for any work with formaldehyde, in order to
contain potential spills
o Keep formaldehyde stored in closed containers in well ventilated
o When possible, ensure that formaldehyde solutions are handled
within a properly functioning chemical fume hood.
o Spill cleanup material should be available in any area where
formaldehyde is used or stored. Products such as formaldehyde
neutralizing powders, or formaldehyde neutralizing pads can be
placed where leaks or drips might occur.
o Provide continuing training and education to personnel.
Engineering Controls
o Ventilation is the most widely applied engineering control method
for reducing the concentration of airborne substances in the
breathing zones of workers. Either local exhaust ventilation or
general dilution ventilation should be used for this purpose
whenever possible.
o The processor and waste room shall be appropriately labeled
regarding the potential danger that exists within the room. Only
persons trained in recognizing the hazards of formaldehyde to are
permitted access to this room.
6. Formaldehyde (Formalin) Personal Protective Equipment (PPE)
Certain types of PPE are effective in controlling formaldehyde
exposure. In normal work situations, PPE should be used only as a
supplement to engineering controls. Employees must not take
formaldehyde-contaminated materials, clothing, or equipment home. At
a minimum, PPE that should be utilized when working with
formaldehyde are:
o Impermeable Gloves: Gloves made of natural or butyl rubber,
Nitrile, or Neoprene are recommended to protect skin from contact
with formaldehyde. Latex gloves should only be used when shortterm, incidental contact is expected. Gloves that have not been
contaminated with formaldehyde may be discarded in the regular
trash. Disposable gloves contaminated with formaldehyde must be
thoroughly rinsed before being discarded in the regular trash.
Heavily contaminated gloves must be disposed of as chemical
o Eye and Face Protection: Always use chemical goggles or a face
shield when handling formaldehyde solutions to minimize the risk of
even a small splash or vapor exposure to the corneas. If a face
shield is worn, chemical goggles are also required if there is a
possibility of a splash to the eyes.
o Lab coats/aprons: An impervious lab coat must be worn,
completely snapped or buttoned, when working with formaldehyde.
In the event that there may be an exposure to a large amount of
formaldehyde, a disposable apron may be utilized in conjunction
with a lab coat and never as the sole clothing barrier to exposure.
o Respiratory Protection: If an employee may be exposed to
formaldehyde vapor concentrations where respiratory protection is
warranted, please contact Safety Management Services for
guidance on appropriate respirators for formaldehyde vapor
protection. When employees are required to wear respirators to
reduce exposure, they must be enrolled in UMHHCs Respiratory
Protection Program as required by OSHA. Work operations which
may warrant respiratory protection include the following:
1. During the installation of engineering controls.
2. Work operations for which engineering controls and work
practices are not feasible.
3. Work operations for which engineering controls and work
practice controls do not reduce employee exposure below the
4. Emergencies.
7. Formaldehyde (Formalin) Storage
Formaldehyde and its solutions should not be stored near strong
oxidizers (e.g., permanganates, nitrates, peroxides, and chlorates),
amines, acids, or alkaline materials. Formaldehyde reacts with HCL
(bleach) to form a potent carcinogen, bis-chloromethyl ether.
Store formaldehyde in labeled, chemically compatible containers, away
from heat and flame. Large volume containers, such as 4-liter bottles,
should be stored under the ducted laboratory hood, or on a low,
protected shelf or in another location where they will not be
accidentally spilled or knocked over. Containers larger than 4-liters
should be stored inside a deep pan or other secondary containment.
Do not store formaldehyde bottles in any area where a leak would flow
to a drain.
Specimen containers should be stored in a tray or a secondary
container such as a heavy duty plastic storage container, so that any
spills would be contained. Formaldehyde storage areas should be
checked weekly for any signs of leakage.
8. Formaldehyde Spills
For small spills of formaldehyde solutions (i.e., less than 50 cc or ml),
apply a formaldehyde absorbent powder such as Spill-X-FP
Formaldehyde Polymerizer. Place all spill clean-up materials in a
labeled, plastic air tight bag and store in a well ventilated area. Do not
use red bags for disposal of formaldehyde spills.
For larger spills (i.e., greater than 50 cc/ml), contain the spill if possible
to do so without exposure to the chemical; otherwise, immediately
leave the area and contact Safety Management Services (764-4427)
Monday thru Friday during regular business hours (8:00 am – 4:30 pm)
or Security (936-7890) after normal business hours (4:30 pm – 8:00
am) and on weekends. If you are splashed with formaldehyde, use the
emergency shower and eyewash immediately, to prevent serious
Managers of laboratories where formaldehyde is utilized shall create
and maintain a program to detect leaks and spills. The leak and spill
detection program should include:
1. Regular visual inspections for leaks and spills.
2. Preventive maintenance of equipment, including surveys for
leaks, at regular intervals.
3. Regular testing of monitoring equipment to assure proper
4. Provisions for formaldehyde spill containment, surface
decontamination, and waste disposal in work areas where
spillage may occur.
5. Prompt cleanup of spills and repair of leaks using persons who
wear appropriate protective clothing and equipment and are
trained in the proper methods for formaldehyde cleanup and
For areas where large amounts of formaldehyde could be released
from an accident or from equipment failure, the area supervisor should
develop and maintain procedures to be followed in the event of an
emergency spill/leak. Any excessive formaldehyde exposure may be
detected by eye or skin irritation, or respiratory distress. Should it be
determined that a leak has occurred it is important to evacuate the
area immediately, contain and clean up the spill (only if properly
trained and personally protected to do so) and to try and keep the
vapors from spreading using any ventilation or protective measures
available. Emergency spill procedures should include/address the
o Spilled material should not be touched by those not properly trained
and lacking proper PPE.
o All ignition sources should be shut off.
o Isolate the hazard area and deny entry to unnecessary persons.
o All persons in severe respiratory distress or suffering from dizziness
or serious skin disorders or other significant medical problems
should be taken to the Emergency Department immediately for
o Contact Safety Management Services (764-4427) Monday thru
Friday during regular business hours (8:00 am – 4:30 pm) or
Security (936-7890) after normal business hours (4:30 pm – 8:00
am) and on weekends and notify staff of the hazardous chemical
leak or spill.
9. Formaldehyde (Formalin) Disposal
Formaldehyde, as for all hazardous chemical waste, must be collected
following the requirements of the UMHHC Hazardous Waste
Management Plan, which can be found at: All
containers must have appropriate lids and be clearly labeled using
UMHHC Hazardous Waste labels.
Biological materials (i.e., human and non-human tissues) preserved in
formaldehyde must be disposed of as medical waste with any
remaining formaldehyde solutions collected and disposed of as
chemical waste. If necessary, the formaldehyde solutions should be
filtered prior to disposal to remove any remaining bits of tissue.
Formaldehyde Policy, Virginia Commonwealth University Office of Health &
Safety Chemical/Biological Safety Section,
University of Medicine and Dentistry of New Jersey EOHSS Guidelines:
Formaldehyde October 2004.
Gile, T. J. (2007, April). Complete Guide to Laboratory Safety (2nd ed.).
Marblehead, MA: HCPro, Inc.
NCCLS. Clinical Laboratory Safety; Approved Guideline—Second Edition.
Document GP17-A2 (ISBN 1-56238-530-5).
NCCLS. Clinical Laboratory Waste Management – Second Edition. Document
GP5-A (ISBN 1-56238-457-0).
Approved by:
Date: _January 1, 2008_
Craig Newman, MS, MBA, MT(ASCP)
Administrative Coordinator
Reviewed by:
Date: July 11, 2008
Brenda Schroeder, BS, MT, CHSP
Administrative Coordinator